Z-1058-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 26, 2014
- Initiation Date
- December 10, 2013
- Termination Date
- March 28, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 119 units
Product Description
External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
Reason for Recall
The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.
Distribution Pattern
Worldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain.
Code Information
Lot Number 1302762, Exp 31 MAY 2018